Staarvisc II

GUDID 00866142000021

0.8 ml, 12 mg/mL Sodium Hyaluronate

Anika Therapeutics, Inc.

Vitreous/aqueous humour replacement medium, intraoperative
Primary Device ID00866142000021
NIH Device Record Keye712c820-fbde-45f3-bdbb-8a1ffbc7971f
Commercial Distribution StatusIn Commercial Distribution
Brand NameStaarvisc II
Version Model Number600-809
Company DUNS807613393
Company NameAnika Therapeutics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100866142000021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZPAid, Surgical, Viscoelastic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-30

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